Approval and Promulgation of State Plans for Designated Facilities; New York

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[Region 2 Docket No. NY 32-194a, FRL-6414-1]

Approval and Promulgation of State Plans for Designated

Facilities; New York

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the

State Plan submitted by New York to implement and enforce the Emission

Guidelines (EG) for existing Hospital/Medical/Infectious Waste

Incinerators (HMIWI). The EG require states to develop plans to reduce

toxic air emissions from all HMIWIs.

DATES: This direct final rule is effective on October 8, 1999 without

further notice, unless EPA receives adverse comment by September 8,

1999. If adverse comment is received, EPA will publish a timely

withdrawal of the direct final rule in the Federal Register and inform

the public that the rule will not take effect.

ADDRESSES: All comments should be addressed to: Raymond Werner, Acting

Chief, Air Programs Branch, Environmental Protection Agency, Region 2

Office, 290 Broadway, 25th Floor, New York, New York 10007-1866.

Copies of the state submittal are available at the following

addresses for inspection during normal business hours:

Environmental Protection Agency, Region 2 Office, Air Programs Branch,

290 Broadway, 25th Floor, New York, New York 10007-1866.

New York State Department of Environmental Conservation, Division of

Air Resources, 50 Wolf Road, Albany, New York 12233.

FOR FURTHER INFORMATION CONTACT: Ted Gardella or Craig Flamm, Air

Programs Branch, Environmental Protection Agency, Region 2 Office, 290

Broadway, 25th Floor, New York, New York 10007-1866, (212) 637-3892 or

(212) 637-4021, respectively.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is EPA taking today?

II. Why is EPA approving New York's State Plan?

III. Why does EPA want to regulate air emissions from HMIWIs?

IV. What are EPA's requirements for HMIWIs?

V. Are any sources exempt from the federal requirements?

VI. What is a State Plan?

VII. What does New York's State Plan contain?

VIII. What sources are affected by New York's State Plan?

IX. What steps do affected sources need to take?

X. What are EPA's conclusions?

XI. Administrative Requirements

I. What Action Is EPA Taking Today?

EPA is approving New York's State Plan submitted on September 9,

1998, and supplemented on March 11, May 12, and May 15, 1999, for the

control of air emissions from HMIWIs throughout the State, except for

those HMIWIs located on Indian Nation land. When EPA developed the New

Source Performance Standards (NSPS) for HMIWIs, we simultaneously

developed the Emission Guidelines (EG) to control air emissions from

older HMIWIs (see 62 FR 48348-48391, September 15, 1997). New York

State developed a State Plan, as required by section 111(d) of the

Clean Air Act (the Act), to adopt the EG into their body of

regulations, and we are acting today to approve New York's State Plan.

Under section 129 of the Act, the EG are not federally enforceable.

Section 129(b)(2) of the Act requires states to submit to EPA for

approval State Plans that implement and enforce the EG. State Plans

must be at least as protective as the EG, and they become federally

enforceable upon approval by EPA. The procedures for adopting and

submitting State Plans are located in 40 CFR part 60, subpart B.

EPA originally issued the subpart B provisions on November 17,

1975. EPA amended subpart B on December 19, 1995, to allow the subparts

developed under section 129 to include specifications that supersede

the general provisions in subpart B regarding the schedule for

submittal of State Plans, the stringency of the emission limitations,

and the compliance schedules, see 60 FR 65414 (December 19, 1995). This

action approves the State Plan submitted by New York to implement and

enforce the EG, as it applies to older HMIWI units.

II. Why Is EPA Approving New York's State Plan?

EPA has evaluated the HMIWI State Plan submitted by New York for

consistency with the Act, EPA guidelines and policy. EPA has determined

that New York's State Plan meets all requirements and, therefore, EPA

is approving New York's Plan to implement and enforce the EG, as it

applies to older HMIWIs.

III. Why Does EPA Want To Regulate Air Emissions From HMIWIs?

When burned, hospital waste and medical/infectious waste emit

various air pollutants, including hydrochloric acid, dioxin/furan,

toxic metals (lead, cadmium, and mercury) and particulate matter.

Mercury is highly hazardous and is of particular concern because it

persists in the environment and bioaccumulates through the food web.

Serious developmental and adult effects in humans, primarily damage to

the nervous system, have been associated with exposures to mercury.

Harmful effects in wildlife have also been reported; these include

nervous system damage and behavioral and reproductive deficits. Human

and wildlife exposure to mercury occur mainly through eating of fish.

When inhaled, mercury vapor attacks also the lung tissue and is a

cumulative poison. Short-term exposure to mercury in certain forms can

cause hallucinations and impair consciousness. Long-term exposure to

mercury in certain forms can affect the central nervous system and

cause kidney damage.

Exposure to particulate matter can aggravate existing respiratory

and cardiovascular disease and increase risk of premature death.

Hydrochloric acid is a clear colorless gas. Chronic exposure to

hydrochloric acid has been reported to cause gastritis, chronic

bronchitis, dermatitis, and photosensitization. Acute exposure to high

levels of chlorine in humans may result in chest pain, vomiting, toxic

pneumonitis, pulmonary edema, and death. At lower levels, chlorine is a

potent irritant to the eyes, the upper respiratory tract, and lungs.

Exposure to dioxin and furan can cause skin disorders, cancer, and

reproductive effects such as endometriosis. These pollutants can also

affect the immune system.

IV. What Are EPA's Requirements for HMIWIs?

On September 15, 1997, under sections 111 and 129 of the Act, EPA

issued the NSPS applicable to new HMIWIs and the EG applicable to older

HMIWIs. The NSPS and EG are codified at 40 CFR part 60, subparts Ec and

Ce, respectively, see 62 FR 48348 (September 15, 1997).

Under the EG, EPA requires that affected older HMIWIs do the

following:

(1) Control emissions for the following designated pollutants:

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particulate matter, sulfur dioxide, hydrogen chloride, oxides of

nitrogen, carbon monoxide, lead, cadmium, mercury, and dioxins and

dibenzofurans.

(2) Control stack opacity.

(3) Include operator training/qualification, waste management

plans, and testing/monitoring of pollutants and operating parameters.

(4) Inspect small incinerator equipment located in rural areas.

The Federal NSPS and EG define an HMIWI as any device that combusts

any amount of medical/infectious waste or hospital waste. The terms

medical infectious waste or hospital waste are defined in 40 CFR

60.51c.

The HMIWI source category is divided into three subcategories based

on waste burning capacity: small (less than or equal to 200 pounds per

hour (lb/hr)), medium (more than 200 lb/hr up to 500 lb/hr), and large

(more than 500 lb/hr).

V. Are Any Sources Exempt From the Federal Requirements?

The following incinerator source categories are exempt from the

federal requirements for HMIWIs:

(1) Incinerators that burn only pathological, low-level radiation,

and/or chemotherapeutic waste (all defined in section 60.51c). However,

the owner or operator must notify the EPA Administrator of an exemption

claim and the owner or operator must keep records of the periods of

time when only pathological, low-level radioactive, and/or

chemotherapeutic waste is burned.

(2) Any unit required to have a permit under section 3005 of the

Solid Waste Disposal Act.

(3) Incinerators that are subject to the NSPS and EG for Municipal

Waste Combustors.

(4) Existing incinerators, processing operations, or boilers that

co-fire medical/infectious waste or hospital waste with other fuels or

wastes and that combust less than ten percent or less medical/

infectious waste and hospital waste by weight (on a calendar quarter

basis). However, the owner or operator must notify the EPA

Administrator of an exemption claim and the owner or operator must keep

records of the amount of each fuel and waste fired.

VI. What Is a State Plan?

Section 111(d) of the Act requires that pollutants controlled under

NSPS must also be controlled at older sources in the same source

category. Once an NSPS is issued, EPA then publishes an EG applicable

to the control of the same pollutant from existing (designated)

facilities. States with designated facilities must then develop a State

Plan to adopt the EG into their body of regulations. States must also

include in their State Plan other elements, such as inventories, legal

authority, and public participation documentation, to demonstrate their

ability to enforce the State Plans.

VII. What Does New York's State Plan Contain?

On September 9, 1998, the New York State Department of

Environmental Conservation (NYSDEC) submitted its section 111(d) State

Plan for implementing EPA's EG for older HMIWI units located in New

York State. This submittal was supplemented by the NYSDEC on March 11,

May 12, and May 15, 1999.

New York has adopted by reference the requirements of the EG in

Part 200 of title 6 of the New York Code of Rules and Regulations

(6NYCRR) of the State of New York, entitled, ``General Provisions'' and

in Subpart 219-1 of 6NYCRR entitled ``Incineration-General

Provisions.'' These adoptions were effective on October 1, 1998. New

York will enforce the requirements under Part 201, entitled, ``Permits

and Registration'' which was also effective on October 1, 1998. By

incorporating the EG by reference into Part 200, NYSDEC has the

authority to include them as applicable requirements in the permits for

the designated facilities and to enforce such requirements. For

consistency, Subpart 219-1, which addresses the applicability of the

various Part 219 Subpart requirements (New York's incineration rules)

now includes the new requirements and necessary definition changes.

New York's State Plan contains the following:

(1) A demonstration of the State's legal authority to implement the

section 111(d) State Plan;

(2) State rules adopted into 6NYCRR as the mechanism for

implementing and enforcing the State Plan;

(3) An inventory of fifteen known HMIWI facilities, including

eighteen incinerator units, along with measurements of their toxic air

emissions;

(4) Emission limits that are as protective as the EG;

(5) Enforceable compliance schedules incorporated into each

facility's existing State operating permit. Compliance dates vary from

one year from the effective date of EPA approval of New York's State

Plan to not later than September 15, 2002;

(6) Testing, monitoring, reporting and recordkeeping requirements

for the designated facilities;

(7) Records for the public hearing; and

(8) Provisions for progress reports to EPA.

New York's State Plan was reviewed for approval with respect to the

following criteria: 40 CFR 60.23 through 60.26, ``Subpart B--Adoption

and Submittal of State Plans for Designated Facilities''; and, 40 CFR

60.30e through 60.39e, ``Subpart Ce--Emission Guidelines and Compliance

Times for Hospital/Medical/Infectious Waste Incinerators.''

VIII. What Sources Are Affected by New York's State Plan?

New York's State Plan regulates all the sources covered by EPA's EG

for older HMIWIs for which construction commenced on or before June 20,

1996. If your facility meets this criterion, you are subject to these

regulations.

IX. What Steps Do Affected Sources Need To Take?

Affected sources must meet the requirements listed in the EG,

summarized as follows:

(1) Determine the size of your incinerator by establishing its

maximum design capacity.

(2) Determine the specific emission limits that apply to you. Each

size category of HMIWI has certain emission limits established that

your incinerator must meet (see Table 1 of 40 CFR part 60, subpart Ce).

The emission limits apply at all times, except during startup,

shutdown, or malfunctions, provided that no waste has been charged

during these events. (40 CFR 60.33e, as listed at 62 FR 48382,

September 15, 1997).

(3) Meet the provisions required of small rural incinerators, if

applicable. (See 40 CFR 60.33e(b), 60.36e, 60.37e(c)(d), and 60.38e(b),

as listed at 62 FR 48380, September 15, 1997).

(4) Meet a 10% opacity limit on your discharge, averaged over a

six-minute block (see 40 CFR 60.33e(c), as listed at 62 FR 48380,

September 15, 1997).

(5) Provide for a qualified HMIWI operator available to supervise

the operation of your incinerator. This operator must be trained and

qualified through a State-approved program, or a training program that

meets the requirements listed under 40 CFR part 60.53c(c) (see 40 CFR

60.34e, as listed at 62 FR 48380).

(6) Provide for operator certification, as discussed in (5) above,

no later than one year after we approve New York's State Plan (see 40

CFR 60.39e(e), as listed at 62 FR 48382).

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(7) Develop and submit to NYSDEC a waste management plan. This plan

must be developed under guidance provided by the American Hospital

Association publication, An Ounce of Prevention: Waste Reduction

Strategies for Health Care Facilities, 1993, and must be submitted to

NYSDEC no later than sixty days following the initial performance test

(see 40 CFR 60.35e, as listed at 62 FR 48380; and 40 CFR 60.38e, as

listed at 62 FR 48381).

(8) Conduct an initial performance test to determine your

incinerator's compliance with these emission limits. This performance

test must be completed by the date specified at 40 CFR 60.37e and 60.8,

as listed at 62 FR 48380.

(9) Install and maintain devices to monitor the parameters listed

under Table 3 to Subpart Ec (see 40 CFR 60.37e(c), as listed at 62 FR

48381).

(10) Document and maintain information concerning pollutant

concentrations, opacity measurements, charge rates, and other

operational data. This information must be maintained for a period of

five years (see 40 CFR 60.38e, as listed at 62 FR 48381).

(11) Report to NYSDEC the results of your initial performance test,

the values for your site-specific operating parameters, and your waste

management plan. This information must be reported within 60 days

following your initial performance test, and must be signed by the

facilities manager (see 40 CFR 60.38e, as listed at 62 FR 48381).

(12) Comply with all the requirements of this State Plan within one

year after we approve it; however, there are provisions to extend your

compliance date (see 40 CFR 60.39e, as listed at 62 FR 48381). Those

sources who have modified their state operating permits to include a

compliance schedule to come into compliance with the State Plan within

a year or more of our approval, must do so by the dates specified in

their individual compliance schedules.

X. What Are EPA's Conclusions?

EPA has determined that New York's State Plan meets all

requirements and, therefore, EPA is approving New York's Plan to

implement and enforce the EG, as it applies to older HMIWIs.

EPA is publishing this rule without prior proposal because the

Agency views this as a noncontroversial submittal and anticipates no

relevant adverse comments. However, in the proposed rules section of

this Federal Register publication, EPA is publishing a separate

document that will serve as the proposal to approve the State Plan

should relevant adverse comments be filed. This rule will be effective

October 8, 1999 without further notice unless the Agency receives

relevant adverse comments by September 8, 1999.

If the EPA receives such comments, then EPA will publish a timely

withdrawal in the Federal Register informing the public that the rule

will not take effect. All public comments received will then be

addressed in a subsequent final rule based on the proposed rule. The

EPA will not institute a second comment period on this rule. Any

parties interested in commenting on this rule should do so at this

time. If no such comments are received, the public is advised that this

rule will be effective on October 8, 1999 and no further action will be

taken on the proposed rule.

XI. Administrative Requirements

Executive Order 12866

The Office of Management and Budget has exempted this regulatory

action from review under Executive Order (E.O.) 12866 entitled

``Regulatory Planning and Review.''

Executive Order 12875

Under Executive Order 12875, EPA may not issue a regulation that is

not required by statute and that creates a mandate upon a State, local

or tribal government, unless the Federal government provides the funds

necessary to pay the direct compliance costs incurred by those

governments. If the mandate is unfunded, EPA must provide to the Office

of Management and Budget a description of the extent of EPA's prior

consultation with representatives of affected state, local, and tribal

governments, the nature of their concerns, copies of any written

communications from the governments, and a statement supporting the

need to issue the regulation. In addition, Executive Order 12875

requires EPA to develop an effective process permitting elected

officials and other representatives of State, local and tribal

governments ``to provide meaningful and timely input in the development

of regulatory proposals containing significant unfunded mandates.''

Today's rule implements requirements specifically set forth by the

Congress in sections 111 and 129 of the Clean Air Act, as amended in

1990, without the exercise of any discretion by EPA. Accordingly, the

requirements of section 1(a) of Executive Order 12875 do not apply to

this rule.

Executive Order 13045

E.O. 13045, entitled ``Protection of Children from Environmental

Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies

to any rule that: (1) is determined to be ``economically significant''

as defined under E.O. 12866, and (2) concerns an environmental health

or safety risk that EPA has reason to believe may have a

disproportionate effect on children. If the regulatory action meets

both criteria, the Agency must evaluate the environmental health or

safety effects of the planned rule on children, and explain why the

planned regulation is preferable to other potentially effective and

reasonably feasible alternatives considered by the Agency.

This rule is not subject to E.O. 13045 because it is not an

economically significant action under Executive Order 12866 and does

not involve decisions intended to mitigate environmental health or

safety risks.

Executive Order 13084

Under Executive Order 13084, EPA may not issue a regulation that is

not required by statute, that significantly or uniquely affects the

communities of Indian tribal governments, and that imposes substantial

direct compliance costs on those communities, unless the Federal

government provides the funds necessary to pay the direct compliance

costs incurred by the tribal governments. If the mandate is unfunded,

EPA must provide to the Office of Management and Budget, in a

separately identified section of the preamble to the rule, a

description of the extent of EPA's prior consultation with

representatives of affected tribal governments, a summary of the nature

of their concerns, and a statement supporting the need to issue the

regulation. In addition, Executive Order 13084 requires EPA to develop

an effective process permitting elected and other representatives of

Indian tribal governments ``to provide meaningful and timely input in

the development of regulatory policies on matters that significantly or

uniquely affect their communities.''

Today's rule implements requirements specifically set forth by the

Congress in sections 111 and 129 of the Clean Air Act, as amended in

1990, without the exercise of any discretion by EPA. Accordingly, the

requirements of section 3(b) of Executive Order 13084 do not apply to

this rule.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency

to conduct a regulatory flexibility analysis of any rule subject to

notice and comment rulemaking requirements unless the agency certifies

that the rule will not

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have a significant economic impact on a substantial number of small

entities. Small entities include small businesses, small not-for-profit

enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial

number of small entities because State Plan approvals under section 111

of the Act do not create any new requirements but simply approve

requirements that the State is already imposing. Therefore, because the

Federal State Plan approval does not create any new requirements, EPA

certifies that this action will not have a significant economic impact

on a substantial number of small entities. Moreover, due to the nature

of the Federal-State relationship under the Clean Air Act, preparation

of flexibility analysis would constitute Federal inquiry into the

economic reasonableness of state action. The Clean Air Act forbids EPA

to base its actions concerning State Plans on such grounds. Union

Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C.

7410(a)(2).

Unfunded Mandates

Under section 202 of the Unfunded Mandates Reform Act of 1995

(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA

must prepare a budgetary impact statement to accompany any proposed or

final rule that includes a federal mandate that may result in estimated

annual costs to state, local, or tribal governments in the aggregate;

or to private sector, of $100 million or more. Under section 205, EPA

must select the most cost-effective and least burdensome alternative

that achieves the objectives of the rule and is consistent with

statutory requirements. Section 203 requires EPA to establish a plan

for informing and advising any small governments that may be

significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not

include a federal mandate that may result in estimated annual costs of

$100 million or more to either state, local, or tribal governments in

the aggregate, or to the private sector. This federal action approves

pre-existing requirements under state or local law, and imposes no new

requirements. Accordingly, no additional costs to state, local, or

tribal governments, or to the private sector, result from this action.

Submission to Congress and the General Accounting Office

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the

Small Business Regulatory Enforcement Fairness Act of 1996, generally

provides that before a rule may take effect, the agency promulgating

the rule must submit a rule report, which includes a copy of the rule,

to each House of the Congress and to the Comptroller General of the

United States. EPA will submit a report containing this rule and other

required information to the U.S. Senate, the U.S. House of

Representatives, and the Comptroller General of the United States prior

to publication of the rule in the Federal Register. This rule is not a

``major rule'' as defined by 5 U.S.C. Sec. 804(2).

Petitions for Judicial Review

Under section 307(b)(1) of the Act, petitions for judicial review

of this action must be filed in the United States Court of Appeals for

the appropriate circuit by October 8, 1999. Filing a petition for

reconsideration by the Administrator of this final rule does not affect

the finality of this rule for the purposes of judicial review nor does

it extend the time within which a petition for judicial review may be

filed, and shall not postpone the effectiveness of such rule or action.

This action may not be challenged later in proceedings to enforce its

requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

Environmental protection, Air pollution control, Intergovernmental

relations, Hospital/Medical/Infectious Waste Incinerators, Reporting

and recordkeeping requirements.

Dated: July 23, 1999.

William J. Muszynski,

Acting Regional Administrator, Region 2.

Part 62, chapter I, title 40 of the Code of Federal Regulations is

amended as follows:

PART 62--[AMENDED]

1. The authority citation for part 62 continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart HH--New York

2. Part 62 is amended by adding Sec. 62.8105 and an undesignated

heading to subpart HH to read as follows:

Metals, Acid Gases, Organic Compounds, Particulates and Nitrogen

Oxide Emissions From Existing Hospital/Medical/Infectious Waste

Incinerators

Sec. 62.8105 Identification of plan.

(a) The New York State Department of Environmental Conservation

submitted to the Environmental Protection Agency a ``State Plan for

implementation and enforcement of 40 CFR part 60, subpart CE, Emissions

Guidelines for Hospitals/Medical/Infectious Waste Incinerators'' on

September 9, 1998 and supplemented on March 11, May 12, and May 15,

1999.

(b) Identification of sources: The plan applies to all existing

HMIWI facilities for which construction was commenced on or before June

20, 1996, as described in 40 CFR Part 60, Subpart Ce.

(c) The effective date for the portion of the plan applicable to

existing Hospital/Medical/Infectious Waste Incinerators is October 8,

1999.

[FR Doc. 99-20305 Filed 8-6-99; 8:45 am]

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